ATLANTA, GA / ACCESSWIRE / April 23, 2019 / Alimera Sciences, Inc. (ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, announces that clinical data for ILUVIEN® will be featured in 15 posters and one podium presentation at the Association for Research and Vision in Ophthalmology (ARVO) Annual meeting April 28-May 2, 2019 in Vancouver, B.C., Canada.
The podium presentation, titled ''Treatment of Non-Infectious Uveitis That Affects The Posterior Segment With A Single Intravitreal Fluocinolone Acetonide Insert - 3-Year Results,'' will highlight three-year data from the clinical trial for ILUVIEN's non-infectious posterior uveitis indication, which recently received approval through the mutual recognition procedure for 17 European Union countries.
''We are very pleased to see the wealth of clinical data accepted for presentation at ARVO, as we believe these data sets provide physicians with important information supporting the efficacy and safety of ILUVIEN for the treatment of both diabetic macular edema and in Europe, non-infectious posterior uveitis,'' said Rick Eiswirth, Alimera's President and Chief Executive Officer. ''As the only non-acute therapy offering patients long term control of their disease, these data presentations provide additional insight into the uniqueness of ILUVIEN.''
April 30, 2019, 4:00-4:15 PM PT, East Ballroom A
Title: ''Treatment of Non-Infectious Uveitis That Affects the Posterior Segment With A Single Intravitreal Fluocinolone Acetonide Insert (FAi) – 3-Year Results''
Author: Dr. Glenn Jaffe, Duke University Eye Center
Monday, April 29, 2019, 4:00-5:45 PM PT, West Exhibition Hall
- Poster B0167: ''First real world analysis of safety in FAc treated eyes receiving additional ocular steroid injection for diabetic macular edema (DME),'' V. Gonzalez
- Poster B0136: ''Retinal Thickness Results Prior and Following Treatment with 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema'' A. Carneiro
- Poster B0170: ''Efficacy and Safety of Fluocinolone acetonide (FAc) implant (ILUVIEN) for treating Diabetic Macular Edema (DME) - A 3-year U.S. Retrospective, multi-center Audit,'' R. Wang
- Poster B0164: “Consistent Improvements in Retinal Thickness Amplitude Achieved with the 0.19mg Fluocinolone Acetonide Implant in Patients with DME: Results from FAME, PALADIN and USER studies,” C. Riemann
- Poster B0147: ''Variation in retinal thickness in relation to corresponding changes in visual acuity in patients receiving the fluocinolone acetonide intravitreal implant for diabetic macular edema,'' M. Habib
- Poster B0153: ''Real-world outcomes from the 3-year European ILUVIEN (0.19 mg fluocinolone acetonide implant) RegIstry Safety Study (IRISS),'' F. Koch
- Poster B0155: ''Efficacy of the 0.19 mg fluocinolone acetonide (FAc) implant (ILUVIEN®) in a multi-physician, single practice setting – The Cleveland Experience,'' D. Daroszewski
- Poster B0161: ''Earlier intervention is associated with improved visual outcomes in patients with persistent or recurrent diabetic edema - Clinical insights from the ILUVIEN (fluocinolone acetonide) Registry Safety Study (IRISS),'' P. Vouzounis
- Poster B0150: ''Interim results from the prospective IDEAL registry study – treatment outcomes achieved with the intravitreal 0.19 mg fluocinolone acetonide implant in German clinical practices,'' R. Khoramnia
- Poster B0149: ''Area-under-the-curve analysis of visual acuity following treatment with the 0.19 mg fluocinolone acetonide implant: Results from the Retro-IDEAL study,'' A. Augustin
- Poster B0144: ''Evaluation of retinal ganglionar cell layer using optical coherence tomography in patients with DME treated with the 0.19 mg fluocinolone acetonide implant,'' B. Pessoa
- Poster B0145: “Discontinuous to Continuous Therapy with 0.2 µg/day Fluocinolone Acetonide implant (FAc) Leads to Reduction in Treatment Frequency for Diabetic Macular Edema (DME),” O. Adams
- Poster B0156: ''Is The Diabetic Macular Edema Chronicity A Prognostic Factor For Functional And Anatomic Outcomes In Patients Treated With 0.19 Mg Fluocinolone Acetonide Implant?'' A. Meireles
- Poster B0163: ''Long-term outcomes in chronic diabetic macular oedema (DMO) for patients treated with the Fluocinolone Acetonide intravitreal implant: Real world UK results,'' B. Mushtaq
Wednesday, May 1, 2019, 4:00-5:15PM PT, West Exhibition Hall
- Poster B0050: ''Global Safety Update: Long Term IOP Outcomes in Patients Receiving the 0.2 μg/day Fluocinolone Acetonide Intravitreal Implant,'' C. Luo
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to control the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Canada, Kuwait, Lebanon and the U.A.E to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids who did not have a clinically significant rise in intraocular pressure. In the EU, ILUVIEN is indicated to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in 17 European countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non non-infectious uveitis affecting the posterior segment of the eye. The 17 EU countries include the UK, Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czech Republic, the Netherlands, and Luxembourg.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.
Forward Looking Statements
This press release contains ''forward-looking statements,'' within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera's belief that these data sets provide physicians with important information supporting the efficacy and safety of ILUVIEN and that they provide additional insight into the uniqueness of ILUVIEN. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change either of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors that could cause actual results to differ include, but are not limited to, other factors discussed in the ''Risk Factors'' and ''Management's Discussion and Analysis of Financial Condition and Results of Operations'' sections of Alimera's Annual Report on Form 10-K for the year ended December 31, 2018, which is on file with the Securities and Exchange Commission and available on its website at http://www.sec.gov.
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